JP6338592B2 - Medical connector with arm - Google Patents

Description

  The present invention relates to an improved connector that allows fluid to flow from a supply tube to an indwelling catheter. More particularly, the invention relates to an enteral nutrition extension set with a special connector that couples to an enteral nutrition device.

  There are many situations where catheter cannulation into a body cavity is required to achieve a desired medical purpose. One relatively common situation is the direct administration of nutrient solutions and nutrients to the stomach and intestines. A stoma (fistula) is constructed in the stomach wall or intestinal wall, and a catheter is placed through the stoma. This surgical opening and the procedure for forming the opening are commonly referred to as “gastrostomy” and “gastrostomy”. A nutrient solution can be infused through a catheter so that nutrients can be administered directly to the stomach and intestines (known as enteral nutrition). Various enteral feeding devices have been developed over the years, some of which are "low profile" exposed on the patient's skin, some of which are conventional, ie non- It is included as well as having a thin structure. These enteral feeding devices are “transconduit catheter”, “percutaneous tube”, “gastrostomy catheter”, “percutaneous gastrostomy catheter”, “PEG catheter”, or “enteral” Also known as “nutrition catheter”. An example of one instrument is shown in US Pat. No. 6,019,746 issued on Feb. 1, 2000 (Patent Document 1).

  Enteral feeding devices function as a passage through the stoma for delivering a nutrient solution from outside the body into the stomach or intestine. During enteral nutrition, the enteral nutrition device is connected to the nutrient solution via a tube with a connector. At this time, the combination of the tube and the connector forms an enteral nutrition extension set. Furthermore, enteral nutrition can take several hours, for example when a patient is sleeping, as a pressurized source (eg a pump) carries the nutrient solution through the tube to the enteral nutrition device and through the enteral nutrition device. Maintaining a strong and leak-proof connection between the tube and the enteral feeding device is an important function of the connector as it may be done overnight. It is also highly desirable for such a connection to withstand torsional forces, torques and tensile forces caused by patient movement.

  However, a problem with thin and non-thin enteral nutrition devices is that it is difficult to connect and remove the enteral nutrition extension set from the base or head portion of the enteral nutrition device. Many prior art enteral feeding devices have a thin base and an indwelling catheter extending from the base. The distal end of the catheter of such enteral feeding device / assembly is often provided with an inflatable balloon to hold the catheter in place in a body cavity such as the gastric lumen.

  Enteral feeding devices often use plugs to block the nutrient supply passage openings formed in the base. The plug is attached to the enteral feeding device by a tether portion. Prior to connecting the enteral nutrition extension set to such a conventional enteral nutrition device, a step of removing the plug from the base portion is required to allow access to the nutritional passage opening.

Other conventional enteral feeding devices are designed with a base or “head” having a locking cover member at the feeding passage opening to the indwelling catheter. The locking cover member is configured to receive a mating connector or an interlocking connector.
Generally speaking, these locking cover members have a keyway, a groove and a stop member, and provide a structure similar to the female portion of the bayonet fitting by providing a slot. A suitable connector that fits into the locking cover member has a dispensing protrusion and a key portion coupled to the protrusion. Such a connector is inserted into the locking cover member and rotated until it locks in place. Exemplary views of these conventional mechanisms can be found in US Pat.

  It can be surprisingly difficult to connect, replace, and / or remove a tube having an interlocking adapter to a locking cover member (such as that described in US Pat. When the field of view of the base part of the enteral feeding device is limited, for example, when the patient is obese or in a dark place, the operation of aligning and removing the interlocking connector with the base part is only for touch. There is no choice but to rely on. If the patient's ability to exercise is reduced, it may be difficult to position, insert, or rotate the connector when fitting the interlocking connector to the locking cover member. Further, in the absence of certainty that this type of connector is properly connected to an enteral feeding device, stomach contents and / or nutrient solutions may leak into the patient's skin surface, clothing, and the like. In addition, if this type of connector is tightly fitted in the base, it will be difficult to remove, so large tensile forces, connected enteral nutrition extension sets and displacement of the base, and even the base Unnecessary displacement of the part is required. All of these can cause leakage or irritate sensitive stoma sites.

  Some conventional interlocking connectors are configured so as to be partially rotatable within the base portion after being fitted into a predetermined position. That is, after inserting the interlocking connector into the locking cover member and turning the connector so that the key portion passes through the “detent”, the interlocking connector is positioned so that the key portion contacts the stop member and the key portion is detented. It can be rotated between the contact positions. Unfortunately, this limited range of motion causes the interlocking connector to transmit torque to the enteral feeding catheter. This transmission of force can cause the catheter to twist or pull, which can cause leaks and irritate sensitive stoma sites. If sufficient force is applied unintentionally, the key portion of the interlocking connector is pushed through the detent, such as when the patient or healthcare provider is removing the locking connector. The key portion after passing the detent can be easily aligned with the slot / keyway, thereby leaving the enteral nutrition extension set unintentionally completely removed.

  There are obvious drawbacks to these conventional connectors, which remain unresolved.

  The need for enteral feeding devices having a thin head or base provides a thin base or head component that is clamped to a percutaneous insertion catheter (ie, a catheter tube) that is inserted from the abdominal wall into the patient's stomach. He also created a conversion kit. Such a thin conversion kit is described in US Pat. No. 5,549,657 (Patent Document 2). According to U.S. Pat. No. 6,057,049, the base or head component has a check valve assembly and a two part clamp. The base or head component functions as the base or head for the catheter after being clamped to the end of the catheter. The check valve assembly includes a circular pedestal. The recess formed under the pedestal is configured to receive lip portions of the snap-fit tube connectors that are snapped into the circular pedestal and arranged opposite to each other. As an example of such a thin conversion kit, C.I. R. The Gauderer Genie (R) PEG system kit commercially available from Bard Nordic (Helsingborg, Sweden), a subsidiary of C.R. Bard, Inc.

  When the patient is ready for enteral nutrition administration using such a snap-on connector, the connector is pressed against the check valve assembly so that the lip of the connector is formed from above the circular base to below the circular base. The connector is snap-fitted to the check valve assembly by fitting into the back. When nutrition is complete, the snap-on connector is removed by pulling out or pulling a set of reinforcing ears positioned opposite each other. The snap-on connector can be easily attached and detached by a set of mutually opposed slots. The slot increases axial and radial distortion and deflection of only the central portion of the snap-on connector when a force is applied to one or both of the ears located opposite each other.

  Connecting, replacing and / or removing a snap-on connector to such a thin enteral feeding head or base is a surprisingly difficult task, at least for the same reason as conventional interlocking adapters. obtain. In addition, by applying a force to push the snap connector to the head part and to remove it from the head part, the force is directly transmitted to the enteral feeding device, thereby causing discomfort and irritating the sensitive stoma site. There is a possibility of being. Since the head portion is thin and relatively small in size (for example, usually about 13 to 25 mm in diameter), the ear portions of the snap-type connectors arranged opposite to each other extend beyond the end of the head portion, Since it may be adjacent to or in contact with the patient's skin, it becomes difficult to pinch and grasp the ear portion with a finger.

  Accordingly, there is a need for a connector for coupling a medical fluid supply tube to a head portion of a catheter device having a circular hub. For example, there is a need for an enteral nutrition extension set connector that allows a user or health care provider to smoothly connect and disconnect the enteral nutrition extension set to the base of an enteral nutrition device. Yes. With such a system, a user or health care provider can smoothly and reliably remove a used connector and connect a new connector, preferably without having to look at the base of the enteral feeding device. be able to.

US Pat. No. 6,019,746 US Pat. No. 5,549,657

  In light of the difficulties and problems discussed herein, the present invention provides that a catheter device (eg, enteral feeding device) includes a circular hub, the circular hub being defined by a radius, a top surface, a peripheral side, and a peripheral side. A connector is provided for coupling a medical fluid supply tube (eg, a “tube”) to a base portion of a catheter device when having a recess. Although the present invention is illustrated in connection with connection to enteral feeding devices and delivery of nutrient solutions, other devices and other fluids (liquids and / or gases) with circular hubs are also envisioned. .

The connector of the present invention includes a cap having a top surface and a bottom surface and including a peripheral region, the peripheral region having a bottom plane and a peripheral edge. The cap further includes at least two arms that are substantially parallel to the bottom plane. Each arm has two ends and extends at at least two sites in the surrounding area so as to releasably engage the annular recess at the arm portion between the two ends . . At least one arm displacement member accessible from the top surface is configured to displace the arm. Each of the two arms may be coupled to the other part of the connector including the arm displacement member only at the two ends. Coupling of the connector to the circular hub is accomplished by placing the connector on the circular hub and pushing the connector downward (ie, toward the catheter device) to engage the arm with the annular recess. To remove the connector, pressing at least one arm displacement member reversibly displaces at least one arm between the two parts of the surrounding region toward the peripheral portion, and removes at least one arm from the annular recess. By doing.

  In one aspect of the invention, each arm can have an upper surface configured to releasably engage an annular recess defined in a circumferential side of the circular hub, and a lower surface, the lower surface of the arm being Can be chamfered. The connector is rotatably coupled to a circular hub on the base of the catheter device. That is, when coupled to the base of the catheter device, the connector will either unintentionally disengage from the enteral feeding catheter device or twist the enteral feeding device either around the circular hub. Can rotate completely in the direction of rotation. The connector may provide a relatively low rotational resistance so that it can be easily displaced under torsional forces or other forces to avoid twisting the enteral feeding tube or transmitting force to the catheter device. desirable.

  The conduit can form a fluid passage through the connector and can be configured to supply a nutrient solution to the lumen of the catheter device. The fluid passages can be spatially positioned or positioned to pass between the arms. The fluid passage may be curved and has one part that has a different orientation than the lumen of the catheter device, such as a 90 degree bend such that the passage portion is generally perpendicular to the lumen of the catheter device. be able to. Alternatively, the fluid passage may be configured to be in the same orientation as the lumen of the catheter device. Such a configuration is desirable for bolus administration of nutrient solutions. The conduit at the proximal end of the connector may take the form of a nozzle configured to engage an orifice or passage opening defined in the hub to supply nutrient solution via the indwelling catheter of the catheter device. Alternatively, the conduit can be configured to engage a nozzle protruding from the surface of the hub to supply a nutrient solution to the indwelling catheter of the catheter device.

  The connector may further include a displacement limiter for limiting the pitching movement of the connector. These displacement limiting portions can be configured to contact the upper surface of the hub or the upper surface of the base portion of the catheter device.

  In one aspect of the invention, the cap, arm and arm displacement member can be made from different materials. Alternatively, the cap, arm and / or arm displacement member may be single or integral and may be formed of the same material. In another aspect of the present invention, the cap has each arm (where each arm engages with the annular recess of the cap) so that the engagement between the annular recess defined on the peripheral side of the circular hub and the arm is visible. It is also possible to have a port located above. In another aspect of the invention, each arm can be reversibly displaced when a force of about 2-14 Newtons is applied to each arm displacement member.

  The present invention also includes an enteral nutrition assembly. The enteral feeding assembly includes (i) an enteral feeding device, comprising a base portion and at least one indwelling catheter or tube having a lumen disposed therethrough, the base portion having a radius. An enteral nutrition device having an upper surface, a peripheral side surface and at least one circular hub having an annular recess defined in the peripheral side surface; and (ii) an enteral nutrition extension set, on the base portion of the enteral nutrition device A connector as outlined above for rotatably coupling the enteral nutrition extension set, which allows fluid communication between the enteral nutrition extension set and the lumen of the enteral nutrition device; It consists of an enteral nutrition extension set.

  The present invention further includes an enteral nutrition extension set. The enteral nutrition extension set includes a medical fluid supply tube and a connector in fluid communication with the tube, and the connector configured to be used with an enteral nutrition device having a circular hub is already schematically illustrated. The connector as described.

FIG. 6 is a perspective view of an exemplary connector for coupling an enteral nutrition extension set to an enteral nutrition device having a circular hub. 2 is a perspective view of the exemplary connector of FIG. 1 coupled to an enteral feeding device having a circular hub. FIG. FIG. 3 is a vertical cross-sectional view taken along line 3-3 showing details of a portion of the exemplary connector of FIG. 2 and a circular hub on the base of the enteral feeding device. FIG. 5 is a perspective view showing details of an exemplary connector including a conduit. FIG. 5 is a sectional view taken along line 5-5 showing details of an exemplary connector including the conduit of FIG. FIG. 5 is an exploded side view showing details of selected components of an exemplary connector. For ease of explanation, certain components such as arms and arm displacement members are not shown. FIG. 5 is a side view showing details of selected components of an exemplary connector. For ease of explanation, certain components such as arms and arm displacement members are not shown. FIG. 6 is a top view showing details of selected components of an exemplary connector. For ease of explanation, certain components such as arms and arm displacement members are not shown. FIG. 3 is a side view of an optional bottom plate of an exemplary connector, showing details of certain components. FIG. 4 is a top view of an optional bottom plate of an exemplary connector, showing details of certain components. FIG. 4 is a top view showing details of an exemplary connector, showing a pair of arms and an arm displacement member in an unstressed or undisplaced state. FIG. 6 is a top view showing details of an exemplary connector, wherein the arm displacement member has been pushed inward in the direction of arrow “B” by a force that causes the arm to be in a stressed or displaced state The figure shows a pair of arms displaced (deflected) in the direction of arrow “A” towards the periphery. FIG. 5 is a top view showing details of an exemplary connector, showing an exemplary pair of arms and arm displacement members disposed on the bottom plate, the arms sandwiching a male connector element on the bottom plate Is arranged. FIG. 9A shows the arm and arm displacement member in an unstressed or undisplaced (undeflected) state. FIG. 5 is a top view showing details of an exemplary connector, showing an exemplary pair of arms and arm displacement members disposed on the bottom plate, the arms sandwiching a male connector element on the bottom plate Is arranged. FIG. 9B shows the arm and arm displacement member in a stressed or displaced (deflection) state, with the male connector element restricting the arm displacement member from moving inward. Yes. 1 is a side view of an exemplary connector. FIG. FIG. 10B is a top view of the exemplary connector of FIG. 10A, showing the arm displacement member in an unstressed or undisplaced state (with an arm not shown). FIG. 10B is a top view of the exemplary connector of FIG. 10A, showing the arm displacement member in a stressed or displaced state (with an arm not shown). FIG. 3 is a bottom view of a portion of an exemplary connector and circular hub of a catheter device, with the connector engaged in an annular recess in the circular hub. FIG. 11A shows the arm displacement member and arm in an unstressed or undisplaced state. FIG. 4 is a bottom view of a portion of a circular hub of an exemplary connector and catheter device, with the connector removed from the annular recess of the circular hub. FIG. 11B shows the arm displacement member and arm in a stressed or displaced state. FIG. 5 is a side perspective view of an exemplary connector, wherein both the proximal and distal ends of the conduit defining the fluid passage are axially aligned with the lumen of the enteral feeding catheter device and the enteral feeding device; It is engaged with the base part. 1 is a bottom view of an exemplary connector. FIG. FIG. 5 is a vertical cross-sectional view illustrating one of various exemplary arms positioned above an annular recess of a circular hub. FIG. 5 is a vertical cross-sectional view illustrating one of various exemplary arms positioned above an annular recess of a circular hub. FIG. 5 is a vertical cross-sectional view illustrating one of various exemplary arms positioned above an annular recess of a circular hub. FIG. 5 is a vertical cross-sectional view illustrating one of various exemplary arms positioned above an annular recess of a circular hub.

  Reference will now be made in detail to one or more embodiments. Examples of embodiments are shown in the drawings. Of course, other embodiments may be created by using the features shown or described as part of one embodiment with another embodiment. The claims are intended to cover these and other modifications and variations as falling within the scope and spirit of the present invention.

  Turning now to the drawings, FIG. 1 illustrates an exemplary connector for coupling a medical fluid supply tube (ie, a tube) to the base of a catheter device (eg, enteral feeding device) having a circular hub. It is a perspective view shown. As used herein, the term “fluid” includes liquids, gases, and combinations of both. Liquids include nutrient solutions and nutrient solutions that can be supplied to a patient via a tube. An example of a gas may be gas released from the patient's stomach or intestine. The connector 10 (sometimes referred to as “enteral feeding extension set connector” or “enteral feeding tube connector” or “tube connector”) has a cap 12. The connector cap 12 has an upper surface 14 and a lower surface 16 and includes a peripheral region 18, which includes a bottom plane 20 (not shown in FIG. 1) and a peripheral edge 22 (not shown in FIG. 1). ). The cap 12 includes at least two arms 24 (not shown in FIG. 1) that extend substantially parallel to the bottom plane 20. Each arm 24 extends between at least two sites 26 in the surrounding region 18. The cap 12 further includes at least one arm displacement member 28 associated with the arm so that the arm can be displaced. The arm displacement member 28 is preferably accessible from the top surface 14 of the cap 12.

  In one aspect of the present invention, one or more of the plurality of arms 24 can be elastic. The arms 24 may be elastic throughout or substantially all. Alternatively, the arm 24 may be elastic in one region but inelastic in another region. For example, the arm 24 may be elastic in the surrounding area 18 and become less elastic or inelastic as it moves away from the surrounding area 18. As used herein, the term “elastic” refers to the ability to rebound or return to its original shape after the material is bent, stretched, or compressed. In the context of the present invention, the arm 24 or a part thereof can be made of an elastic material that can be reversibly displaced. Suitable materials include polyethylene terephthalate, polypropylene, high density and low density polyethylene, nylon, polyurethane, silicone and natural and synthetic elastomers. Mixtures and combinations of these materials can also be used. These materials desirably form an arm that is easily displaceable and will return to its original shape or state. Alternatively, the arm may be substantially rigid but displaceable or displaceable, and the arm displacement member may be elastic so that the position of the arm 24 can be reversibly displaced. It may be.

  The connector may also include a conduit 32 formed with a fluid passage for delivering a nutrient solution from the tube 34 to the lumen of the enteral feeding device 36.

  FIG. 1 shows a state in which the enteral nutrition extension set connector 10 is disposed above the enteral nutrition device 36. Enteral feeding device 36 includes a base portion 38, which has a circular hub 40. The circular hub has a radius “R”, a top surface 42, a peripheral side surface 44 and an annular recess 46 defined in the peripheral side surface 44. In other words, in the circular hub 40, a rim, collar, rib, lip or flange structure 48 is formed by extending a generally horizontal top surface 42 beyond a generally vertical peripheral side surface 44. Thereby defining an annular recess 46 below which is sized to engage the arm 24 of the connector 10. The radius “R” is the distance from the center of the hub 40 to the outermost edge “E” of the portion of the top surface 42 that forms the rim, collar, rib, lip or flange structure 48 that defines the annular recess 46. The circular hub 40 also includes a passage opening or orifice “O” in the center of the hub. When the connector 10 is not engaged with the circular hub 40, it is desirable to seal the orifice “O” using a valve “V”.

  Generally speaking, the arm 24 is configured to removably engage an annular recess 46 defined in the peripheral side 44 of the circular hub 40. Arm 24 is shown in FIG. 13, which is a bottom view of an exemplary connector. Examples of other arms 24 can also be seen in FIGS. 8A, 8B, 9A, 9B, 11A and 11B. The connector 10 is coupled to the circular hub 40 by pressing the connector against the hub until the arm engages an annular recess defined in the circumferential side of the circular hub. Of course, the connection of the connector 10 to the circular hub 40 is achieved by pressing the arm displacement member 28 between fingers so that the arm forms a rim, collar, rib, lip or flange structure 48. The arm is deformed or displaced as it passes through the outermost edge “E” of 42, the connector 10 is placed on the circular hub 40, and then the arm 24 is removed from the annular recess except for the pressing force applied to the arm displacement member 28. This can be done by engaging 46. Removal of the connector from the hub reversibly displaces the arm 24 toward the peripheral edge 22 (eg, radially outward from the hub 40) by squeezing the arm displacement member 28, thereby causing the arm 24 to ring This is done by separating from the recess 46. The connector is preferably rotatably coupled to a circular hub on the base of the enteral feeding device. That is, the connector can fully rotate in either direction of rotation around the circular hub without detaching from the enteral feeding device or twisting the enteral feeding device. The connector is preferably rotatably coupled so that it can rotate freely about the circular hub with relatively low resistance. 1, 2, and 3, there is also shown a port or opening 50 for allowing the engagement between the arm 24 and the annular recess 46 to be seen, and the port 50 is connected to each arm 24 in the cap 12. Is positioned above the position where it engages with the annular recess 46.

  Referring now to FIG. 2, a perspective view showing the connector 10 coupled to the enteral feeding device 36 is shown. In FIG. 2, an optional port 50 is shown to allow visual engagement between the arm 24 and the annular recess 46. More specifically, the outermost edge of the rim, collar, rib, lip or flange structure 48 is visible through the port 50.

  Referring now to FIG. 3, there is shown a vertical sectional view taken along line 3-3 showing details of the connector 10 of FIG. 2 when coupled to an enteral feeding device 36. FIG. In this view, the cap 12 is in contact with the circular hub 40. A fluid passage 70 may be defined through the conduit 32 of the connector 10. As shown in FIG. 3, the arm 24 is engaged with an annular recess 46 defined in the peripheral side surface 44 of the circular hub 40. The arm is held in association with the cap 12 by a structure not shown in FIG. In addition, the connector 10 has a pitching / rolling movement of the connector (i.e., so that the peripheral portions of the connector can move up or down, and the opposing peripheral portions of the connector can be displaced in opposite directions to each other). In addition, a displacement limiting portion 80 may be included to limit movement or vibration about an axis parallel to the passage opening defined in the hub and perpendicular to the top surface of the hub or the top surface of the base portion. More specifically, the cross-sectional view of FIG. 3 is a pair of displacement limiting portions 80 that are integrated or coupled to a portion of the cap 12 and that contact the top surface of the hub 40. Shows what is configured to do. It is considered that the cap 12 and the displacement limiting portion 80 can be configured so that the displacement limiting portion 80 can come into contact with the upper surface 82 of the base portion 38 of the enteral feeding device 36. Alternatively and / or in addition, the displacement limiter 80 may form part of the conduit 32 or more desirably form part of the arm 24 or the arm displacement member 28.

  The arm displacement member 28 helps the user to identify the arm displacement member 28 by visual and / or tactile identification marks, such as bands, irregularities, protrusions, potches, random textures, contrast colors, etc. Can have the following topography. Alternatively and / or in addition, the cap 12 of the enteral nutrition extension set connector 10 may include a mark “I” as shown in FIGS. These marks “I” can be used to provide the user with tactile or visual cues about the position of the arm displacement members and / or the direction in which they are pushed, squeezed or pinched.

  Referring now to FIGS. 4 and 5, FIG. 4 shows a perspective view of the connector 10 including a conduit 32 that forms a fluid passage 70 through the connector, and FIG. 5 shows the fluid passage through the connector. FIG. 5 shows a cross-sectional view of the connector 10 of FIG. 4 along line 5-5 including the formed conduit 32; The conduit 32 is configured to supply a nutrient solution from the tube 34 to the lumen of the enteral feeding device 36. The proximal end 72 of the conduit 32 that forms the fluid passageway is axially aligned with the lumen of the enteral feeding device, and then a 90 degree bend is provided so that the distal end 74 of the conduit 32 is connected to the proximal end 72. However, it may extend generally vertically. This configuration is useful for most nutritional applications. Alternatively, the proximal end 72 of the conduit 32 forming the fluid passageway 70 is axially aligned with the lumen of the enteral feeding device, after which the distal end 74 of the conduit 32 is axially aligned with the proximal end. You may make it continue extending in the state. Such an arrangement is shown in the side perspective view of FIG. FIG. 7 shows the enteral nutrition extension set connector 10 coupled to the base portion 38 of the enteral nutrition device 36. Such a configuration is desirable for bolus administration of nutrient solutions.

  The conduit 32 may take the form of a nozzle as shown schematically in FIGS. 3, 5, 6A, 6B, 10A and 13. The nozzle extends beyond the bottom plane 20 of the connector to engage an orifice “O” defined in the hub 40 for supplying nutrient solution to a lumen formed in the indwelling catheter of the enteral feeding device. Is configured to do. Alternatively, the conduit 32 may be configured to engage a nozzle (not shown) that protrudes from the top surface of the hub for supplying nutrient solution.

  Generally speaking, the connector 10 is disposed directly above the circular hub for coupling to the circular hub 40. When pushed down to the circular hub, the connector is coupled to the circular hub 40 in contact with the following areas of the circular hub: top surface 42, edge "E", rim or flange structure 48, and annular recess 46. The When a downward force is applied to the connector, the cap 12 as the arm 24 slides over the rim or flange structure 48 upper edge “E” of the circular hub 40 (as shown in FIG. 3). The arm 24 bends easily. The upper surface 110 of the arm engages an annular recess 46 defined in the peripheral side 44 of the circular hub 40. The arm 24 is below (not shown) a generally horizontal top surface 42 that extends above a generally vertical peripheral side surface 44 that forms a rim, collar, rib, lip or flange structure 48 that defines an annular recess 46. It is comprised so that it may engage / disengage with.

  The downward force required to couple the connector 10 to the circular hub 40 is typically less than about 10 Newtons and desirably about 0.1-8 Newtons. Such a low level of force is very important. The reason is that the downward force is transmitted directly to the enteral feeding device present at the sensitive stoma site. This configuration avoids the higher level of force required to couple the snap-on connector in place. Unlike such “high force” coupling connectors, the present invention avoids irritation to sensitive stoma sites. The low level of force used to engage the connector can be a movement-impaired patient, a visually-impaired patient, or other patient who has difficulty viewing or reaching the enteral feeding device (e.g., Obese patients, patients with reduced exercise capacity, etc.).

  The arm 24 also provides a clear tactile cue when fitted in an annular recess 46 defined in the peripheral side 44 of the hub. As the connector is pressed against the hub, it gradually slides into contact with the upper surface 42 of the hub and bends (displaces) radially toward and near the area defined by the edge “E” so that the arm 24 Can convey a sense of increasing resistance. Such resistance disappears as soon as the arm enters the annular recess and a tactile signal is issued. This action can also give an audible cue that can be characterized as a “click” or “click” to inform the user that the engagement is correctly placed in the annular recess. These tactile and audible cues help to inform the user and health care provider that a proper and secure connection has been made.

  In accordance with the present invention, the connector 10 is removed from the circular hub 40 by squeezing or pushing the arm displacement member 28 to reversibly displace the arm 24 radially outward toward the peripheral edge 22. When the arm displacement member 28 is pressed or squeezed, the arm 24 is radially outward and circular so that it is located at or passes through the edge “E” of the structure 48. It is spatially displaced in a direction away from the hub 40. The displacement of the arm 24 is caused by bending or deformation of the arm. For example, each arm 24 can be made of a material that changes its spatial shape but is reversible when a force of about 2-14 Newtons is applied to the respective arm displacement member 28. Exemplary materials include polyethylene terephthalate, polypropylene, high density and low density polyethylene, nylon, natural and synthetic elastomers and silicones that are not “brittle”, and combinations / mixtures thereof. It is believed that the arm may have a thinner area than the other parts. Alternatively and / or in addition, it is contemplated that the arm may be pre-curved or bent to preferentially displace in a particular direction. The arms may also be stepped or various levels of thickness to improve elastic properties or to control the range and / or position of elasticity so that each arm is reversibly deformable. It is also conceivable that A feature of the present invention is that the arm is reversibly deformable to engage and disengage from the hub. To avoid transmitting to the patient a force that can cause irritation (eg, at the stoma site) and to allow secure connection / removal without requiring an unnecessarily high level of force (entire cap) By adjusting the elasticity of the arm (rather than requiring that it be elastic), it is believed that the force required to engage and disengage the connector and the circular hub can be more carefully controlled.

  Referring now to FIGS. 6A, 6B, and 6C, examples of selected components of the exemplary connector 10 are shown. FIG. 6A is an exploded side view of these selected components of connector 10, with cap 12 having upper surface 14 and lower surface 16 (including female connector element 200) and including peripheral region 18, and conduit 32. And an optional bottom plate 300 (including male connector element 302). FIG. 6B shows how these components are combined into a connector 10. For ease of explanation, the arms and arm displacement members are not shown in FIGS. 6A and 6B. 6C is a top view of the assembled components of FIG. 6B. For simplicity, the arm and arm displacement member are not shown in FIG. 6C, but the upper surface 14, the upper portion of the conduit 32, the peripheral edge 22 of the surrounding region 18 (and the female connector element 200 depicted in broken lines). ) Is shown.

  FIG. 7A is a side view of the optional bottom plate 300 of the exemplary connector 10, showing the male connector element 302 that couples to the female connector element 200 of the cap 12. FIG. 7B is a top view of the optional bottom plate 300 showing a male connector element 302 and a hole 304 through the bottom plate 300. Hole 304 allows enteral feeding device circular hub 40 to be inserted through bottom plane 20 and into cap 12.

  FIG. 8A is a top view of an exemplary configuration of a pair of arms 24 and arm displacement member 28. In this figure, the arm 24 is not displaced (not bent). As seen in the top view of FIG. 8B, the arm displacement member 28 was pushed inward by force “B” to reach a deformed or displaced (deflection) state as shown. The pair of arms 24 is then displaced in the direction indicated by arrow “A” toward the peripheral edge 22 (not shown in FIG. 8B) of the cap 12. The original state of the arm 24 and the arm displacing member 28 that are not displaced are indicated by broken lines.

  FIG. 9A is a top view of the arm 24 and the arm displacement member 28 disposed on the bottom plate 300, and the pair of arms 24 is disposed at a position sandwiching the male connector element 302 and penetrates the bottom plate 300. It is placed over the hole 304. In FIG. 9A, the arm 24 is not displaced (not flexed). That is, the force or pressure for causing the displacement (deflection) of the arm 24 is not applied to the arm displacement member 28. FIG. 9B is a top view of the arm 24 and the arm displacement member 28, which is disposed on the bottom plate 300 and applies a force or pressure to the arm displacement member 28 to cause displacement of the arm 24. It has a displaced configuration caused by the addition. As seen in FIG. 9B, the male connector element 302 restricts the arm displacement member 28 from moving inward. The male connector element 302 also limits the amount of force that can be applied to the arm 24.

  FIG. 10A is a side view of the exemplary connector 10 where the cap 12, bottom plate 300, conduit 32 and arm displacement member 28 are other components not shown (eg, arm 24, male connector element, It is shown assembled with a female connector element, etc.). 10B is a top view of the connector 10 of FIG. 10A showing the top surface 14 of the cap 12, the conduit 32, and the arm displacement member 28. FIG. In this figure, the arm displacement member is not displaced. That is, no force or pressure for causing the arm 24 to be displaced is applied to the arm displacement member 28. 10C is a top view of the connector 10 of FIG. 10A, showing the top surface 14 of the cap 12, the conduit 32, and the arm displacement member 28. FIG. In this figure, the arm displacement member is in a displaced state. That is, a force or pressure is applied to the arm displacement member 28, whereby the arm displacement member 28 is displaced inwardly (that is, toward the peripheral region 22 of the cap 12), thereby causing the displacement of the arm 24. .

  FIG. 11A is a bottom view of the exemplary connector 10 in place and engaged with a portion of the exemplary circular hub 40 of the enteral feeding device 36. FIG. 11A shows two arm displacement members 28 a and 28 b, two elastic elements 306, and two arms 24 engaged with the annular recess of the circular hub 40, along with the cap 12. A first end 308 of each arm 24 is coupled to a pivot 310 so that the arm 24 is displaced (eg, pivoted) by a certain amount in the pivot 310 in a direction parallel to the bottom plane. Can do. The second end 312 of the arm is within the respective arm displacement member 28 b (ie, the arm displacement member 28 b at the second end 312 of the arm 24) or between the respective arm displacement member 28 b and the lower surface 16 of the cap 12. It can be freely displaced in a pocket 314 formed therebetween (for example, a recess in which a slot is formed). The arm displacement member 28 a closest to the pivot attachment portion 310 is in contact with at least one arm 24. The arm displacing member 28 a displaces the second end 312 of the arm 24 while being in contact with the first end 308 of the arm 24, thereby moving the second end 312 toward the peripheral portion 22. The hub 40 is configured to be detached from the annular recess. When the arm displacing member 28a (or both arm displacing members 28a and 28b) is pushed inward toward the circular hub 40, the elastic element 306 moves the arm 24 toward the periphery 22 as shown in FIG. 11B. Is reversibly compressed so that it can be displaced, but there is no force applied by the arm displacement member 28 (or by the downward force that can be applied to the cap as it is placed on the hub) In turn, the elastic element 306 returns the arm 24 to a position for engaging the annular recess of the circular hub 40. The elastic element 306 may include one or more flexible elastic foams, compressible elastomeric materials, elastic bands or strips, compressible bladders, metal or plastic pieces, springs (eg, compression coil springs). , Cantilever springs, spiral springs or pruning springs, conical coil springs, and the like, and combinations thereof.

  Referring again to FIG. 5, each arm 24 is configured to removably engage an annular recess defined in the circumferential side of the circular hub. Each arm 24 desirably may have a top surface 110. The top surface 110 is configured to be adjacent to the underside (not shown) of the rim, rib, lip or flange structure 48 of the annular recess 46. Each arm can also have a lower surface 112. Desirably, a portion of the lower surface 112 may have a chamfer 114. The chamfer 114 can be adjusted to provide a sufficient angle to allow easier attachment to the hub when the connector 10 is pressed down against the circular hub 40. The presence of the chamfered portion 114 helps to avoid the application of forces that cause discomfort and stimulate the sensitive stoma site. 14A-14D, vertical cross-sectional views (not to scale) showing various exemplary cross-sectional shapes that can be utilized with the arm 24 of the present invention to engage an annular recess in a circular hub. )It is shown. As seen in FIG. 14A, the arm 24 may take the form of a parallelogram having an upper surface 110 and a lower surface 112 (or the arms have sides that are not parallel to each other and have an angle less than or greater than 180 °. Can also be defined). Vertically by the rim, rib, lip or flange structure 48 by providing an angle sufficient to allow easier attachment to the hub when the connector 10 is pressed downwardly onto the top surface 42 of the circular hub 40. It is desirable that the sides can be inclined as shown in FIG. 14A so that the connector can be engaged in an annular recess 46 defined in the peripheral surface. Generally speaking, FIG. 14A shows a generally rhomboid or rhomboid cross section. FIG. 14B shows an arm 24 having a triangular cross-sectional shape with an upper surface 110. FIG. 14C shows an arm 24 having a generally trapezoidal cross-sectional shape having an upper surface 110, a lower surface 112 and a chamfered portion 114. It is contemplated that the arm 24 may have an unequal quadrilateral cross-sectional shape with no sides parallel. It is also contemplated that the arm may have a cross section characterized by a combination of straight and non-linear sides. As an example, FIG. 14D shows an arm 24 having a generally circular cross-sectional shape. The arm may have a semi-circular, partially circular, semi-oval, partially oval shape, or other shape consisting of a combination of straight and non-linear sides (each side is a connector 10 can be adjusted to provide an angle or surface that is configured to allow easier attachment to the hub when pressed 10 against the circular hub 40 downward. It is done.

  As described above, the connector includes a cap 12. The cap 12 may have a bivalve shape or a bowl shape. A portion of the cap 12 can be coupled to an optional bottom plate 300 (as shown in FIGS. 6A and 6B), or so that the cap 12 and the bottom plate 300 are single or integral. The cap 12 can also be formed as a single element. In one aspect of the invention, the various structural members of connector 10 can all be formed separately and later joined together by techniques (single or combined) including gluing, fusing, overmolding, and the like.

  Referring now to FIG. 13, a bottom view of the exemplary connector 10 of FIG. In this figure, an optional displacement limiting portion 80 is disposed in the vicinity of the peripheral edge portion 22. As seen in FIG. 9, the arm 24 extends at at least two sites in the peripheral region 20 so as to be releasably engaged with an annular recess 46 formed in the circular hub 40. doing. Further, the arm 24 can be arranged in alignment with the port 50 directly below the port 50 for allowing visual engagement with the circular hub.

  In accordance with the present invention, the connector 10 is “rotatably coupled” to the circular hub 40. That is, the connector rotates freely around the entire circumference of the circular hub when coupled to the base portion of the enteral feeding device. If the connector passes a position or place that strikes a mechanism such as a keyway, groove, slot, or the like, the connector will be unintentionally disconnected, and a stop member, detent, etc. While striking a mechanism, or the like, will prevent or prevent full rotation about the hub, which will twist the enteral feeding device, the connector of the present invention It is configured to freely rotate the entire circumference of the hub without becoming the latter. It is desirable that the connector be configured to rotate the entire circumference of the hub multiple times while causing little or no resistance so that the enteral feeding device is not twisted or rotated.

  The present invention also includes an enteral nutrition assembly. The enteral feeding assembly includes (i) an enteral feeding device including a base portion and a catheter having a lumen disposed therethrough, the base portion having a radius, a top surface, a peripheral side surface, and And (ii) an enteral nutrition extension set with a connector for rotatably coupling to a base part of an enteral feeding device. The connector is as already outlined.

  The present invention further includes an enteral nutrition extension set. The enteral nutrition extension set includes a medical fluid supply tube and a connector for use with an enteral nutrition device having a circular hub. The connector is as already outlined.

  Although the invention has been described in connection with specific preferred embodiments, it is to be understood that the subject matter encompassed by the invention is not limited to such specific embodiments. On the contrary, the subject matter of the present invention is intended to cover all alternatives, modifications and equivalents that may be included within the spirit and scope of the invention.

Claims (14)

A connector for coupling a medical fluid supply tube to a head portion of a catheter device having a circular hub having an annular recess defined on a peripheral side,
A cap having a top surface and a bottom surface and including a peripheral region, the peripheral region having a bottom plane and a peripheral edge;
At least two arms substantially parallel to the bottom plane, each of the two arms having two ends, wherein the annular recess is in the arm portion between the two ends. as disengageably engaged, the configured so that the cross bar so as to straddle the bottom surface between two concave portions facing radially mutually defined around the area, the at least two Arm,
Arm displaceable members respectively disposed at the concave portions in the surrounding area, each directly coupled to both of the two arms so as to be able to displace the arms and accessible from the top surface Including
The arm displacement members are coupled to each other only by the two arms;
Each of the two arms is coupled to the other part of the connector including the arm displacement member only at the two ends,
The connector is configured to be able to freely rotate the entire circumference of the circular hub,
The at least one arm displacement member is pushed radially toward the corresponding concave portion in the peripheral region toward the mutually opposite concave portions, thereby the two concave shapes in the peripheral region. The connector can be removed from the circular hub by reversibly displacing at least one arm between the parts toward the peripheral edge within the cap and detaching from the annular recess. Characteristic connector.   The connector of claim 1, wherein at least one arm comprises a resilient material.   The connector is placed on the hub by placing the connector on the hub and pressing the upper surface of the cap to displace the lower surface of the cap toward the hub until the arm engages the annular recess. The connector according to claim 1, wherein the connector is configured to be coupled.   The said cap has a port for enabling the engagement between the arm and the annular recess to be visually recognized, and the port is located above at least one arm. Connector.   The connector according to claim 1, wherein each arm is configured to be spatially displaced when a force of about 2 to 14 Newtons is applied to the at least one arm displacement member.   The connector according to claim 1, further comprising a displacement limiting portion for limiting pitching movement of the connector.   The connector according to claim 1, wherein each arm has an upper surface configured to detachably engage with the annular recess, and a lower surface having a chamfered portion.   The connector of claim 1, further comprising a conduit forming a fluid passage through the connector, the conduit configured to supply liquid to a passage formed in the catheter device. . Enteral nutrition assembly,
A base portion, at least one passage disposed through the base portion, and at least one circular hub on the base portion, the circular hub defining a radius, a top surface, a peripheral side surface and the peripheral side surface; An enteral feeding device having an annular recess,
An enteral nutrition extension set comprising the connector according to claim 1,
An enteral nutrition assembly, wherein the connector is configured to allow fluid communication between the enteral nutrition extension set and at least one passageway of the enteral nutrition device. A connector for an enteral nutrition extension set for coupling to a circular hub of an enteral nutrition device having a radius, a top surface, a peripheral side and an annular recess defined in the peripheral side,
A cap having a top surface and a bottom surface and including a peripheral region, the peripheral region having a bottom plane and a peripheral edge;
At least two arms, each of the two arms having two ends, such that the arm portion between the two ends removably engages the annular recess. configured so that the cross bar so as to straddle the bottom surface between the concave portion facing in the radial directions defined around the area, and the at least two arms,
An arm displacement that is disposed in each of the concave portions in the surrounding region, each directly coupled to both of the two arms to allow the arm to be displaced, and accessible from the top surface. Including members,
The arm displacement members are coupled to each other only by the two arms;
Each of the two arms is coupled to the other part of the connector including the arm displacement member only at the two ends,
Further comprising a conduit configured to form a fluid passage through the connector and to supply a nutrient solution to the lumen of the enteral nutrition device;
The connector is configured to freely rotate around the entire circumference of the circular hub;
The at least one arm displacement member is pushed radially toward the corresponding concave portion in the peripheral region toward the mutually opposite concave portions, thereby the two concave shapes in the peripheral region. The connector can be removed from the circular hub by reversibly displacing at least one arm between the parts toward the peripheral edge within the cap and detaching from the annular recess. Characteristic connector.   The connector according to claim 10, wherein at least one arm is elastic.   The cap has a port for allowing visible engagement between the arm and the annular recess defined in the peripheral side of the circular hub, the port being located above the at least one arm. The connector according to claim 10.   The connector according to claim 10, wherein each arm has an upper surface configured to detachably engage with the annular recess, and a lower surface having a chamfered portion. Enteral nutrition extension set,
Tubes,
A connector in fluid communication with the tube and configured to rotatably couple to an enteral feeding device having a circular hub defining an annular recess on a peripheral side ;
The connector is
A cap having an upper surface and a lower surface and including a peripheral region, the peripheral region having a peripheral edge;
And at least two arms, each of said two arms having two ends, is detachably engaged with the annular recess of said circular hub the arm portion between said two ends as such, the configured so that the cross bar so as to straddle the bottom surface between the concave portion facing in the radial directions defined around the area, and the at least two arms,
An arm displacement that is disposed in each of the concave portions in the surrounding region, each directly coupled to both of the two arms to allow the arm to be displaced, and accessible from the top surface. Including members,
The arm displacement members are coupled to each other only by the two arms;
Each of the two arms is coupled to the other part of the connector including the arm displacement member only at the two ends,
A conduit configured to form a fluid passage through the connector and to supply a nutrient solution to the passage of the enteral feeding device;
The connector is coupled to the circular hub by the arm engaging the annular recess so that the connector rotates freely around the entire circumference of the circular hub;
By pushing at least one arm displacement member radially toward the concave portions that are radially opposite to each other in the peripheral region, the arm is pushed with respect to the peripheral region. An enteral nutrition extension set characterized in that the connector can be removed from the circular hub by reversibly displacing and detaching from the annular recess.

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